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Claims for Patent: 6,784,177

Claims for Patent: 6,784,177

Title:

Methods using hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate

Abstract:

The present invention provides methods of treating and preventing mortality associated with heart failure in an African American patient with hypertension, and improving oxygen consumption, quality of life and exercise tolerance by administering a therapeutically effective amount of at least one hydralazine compound and at least one of isosorbide dinitrate and isosorbide mononitrate, and, optionally, one or more compounds, such as, for example, a digitalis, a diuretic compound, or a compound used to treat cardiovascular diseases. In the present invention, the hydralazine compound is preferably hydralazine or a pharmaceutically acceptable salt thereof. Preferred methods of the invention comprise administering hydralazine or a pharmaceutically acceptable salt thereof and isosorbide dinitrate.

Inventor(s):

Cohn; Jay N. (Minneapolis, MN), Carson; Peter (Chevy Chase, MD)

Assignee:

Nitro Med, Inc. (Bedford, MA)

Application Number:

10/210,113

Patent Claims:

1. A method of reducing mortality associated with heart failure in a black patient in need thereof comprising administering to the black patient hydralazine or a
pharmaceutically acceptable salt thereof in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide dinitrate in an amount of about 20 milligrams per day to about 200 milligrams per day.

2. A method for improving oxygen consumption in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about 30 milligrams per day to about 300
milligrams per day and isosorbide dinitrate in an amount of about 20 milligrams per day to about 200 milligrams per day.

3. A method of reducing mortality associated with heart failure in a black patient comprising administering to the black patient a therapeutically effective amount of: (i) at least one hydralazine compound or a pharmaceutically acceptable salt
thereof; (ii) at least one of isosorbide dinitrate and isosorbide mononitrate; and (iii) optionally, one or more compounds selected from the group consisting of a digitalis compound, a diuretic compound, potassium, an angiotensin-converting enzyme
inhibitor, a beta-adrenergic blocker, a cholesterol reducer, a calcium channel blocker, an angiotensin II receptor antagonist, and an endothelin antagonist.

6. The method of claim 3, wherein the hydralazine compound is hydralazine hydrochloride.

7. The method of claim 3, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered to the black patient as components of the same composition or as separate
components.

8. A method for improving oxygen consumption in a black patient in need thereof comprising administering to the black patient a therapeutically effective amount of: (i) at least one hydralazine compound or a pharmaceutically acceptable salt
thereof; (ii) at least one of isosorbide dinitrate and isosorbide mononitrate; and (iii) optionally, one or more compounds selected from the group consisting of a digitalis compound, a diuretic compound, potassium, an angiotensin-converting enzyme
inhibitor, a beta-adrenergic blocker, a cholesterol reducer, a calcium channel blocker, an angiotensin II receptor antagonist, and an endothelin antagonist.

11. The method of claim 8, wherein the hydralazine compound is hydralazine hydrochloride.

12. The method of claim 8, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered to the black patient as components of the same composition or as separate
components.

13. The method of claim 3, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide dinitrate is
administered in an amount of about 20 milligrams per day to about 200 milligrams per day.

14. The method of claim 3, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide mononitrate is
administered in an amount of about 10 milligrams per day to about 120 milligrams per day.

15. The method of claim 3, wherein the black patient is male.

16. The method of claim 3, wherein the black patient is female.

17. A method for reducing mortality associated with heart failure in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about 30 milligrams per
day to about 300 milligrams per day and isosorbide mononitrate in an amount of about 10 milligrams to about 120 milligrams per day.

18. The method of claim 8, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide dinitrate is
administered in an amount of about 20 milligrams per day to about 200 milligrams per day.

19. The method of claim 8, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide mononitrate is
administered in an amount of about 10 milligrams per day to about 120 milligrams per day.

20. The method of claim 8, wherein the black patient is male.

21. The method of claim 8, wherein the black patient is female.

22. A method for improving oxygen consumption in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about 30 milligrams per day to about 300
milligrams per day and isosorbide mononitrate in an amount of about 10 milligrams to about 120 milligrams per day.

23. A method for treating hypertension in a black patient in need thereof comprising administering to the black patient a therapeutically effective amount of: (i) at least one hydralazine compound or a pharmaceutically acceptable salt thereof;
(ii) at least one of isosorbide dinitrate and isosorbide mononitrate; and (iii) optionally, one or more compounds selected from the group consisting of a digitalis compound, a diuretic compound, potassium, an angiotensin-converting enzyme inhibitor, a
beta-adrenergic blocker, a cholesterol reducer, a calcium channel blocker, an angiotensin II receptor antagonist, and an endothelin antagonist.

24. The method of claim 23, further comprising administering a pharmaceutically acceptable carrier.

26. The method of claim 23, wherein the hydralazine compound is hydralazine hydrochloride.

27. The method of claim 26, wherein the hydralazine hydrochloride is administered in an amount of about 30 milligrams per day to about 300 milligrams per day.

28. The method of claim 23, wherein the isosorbide dinitrate is administered in an amount of about 20 milligrams per day to about 200 milligrams per day.

29. The method of claim 23, wherein the isosorbide mononitrate is administered in an amount of about 10 milligrams per day to about 120 milligrams per day.

30. The method of claim 23, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered to the black patient as components of the same composition.

31. The method of claim 23, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered to the black patient as separate components.

32. The method of claim 23, wherein the black patient is male.

33. The method of claim 23, wherein the black patient is female.

34. The method of claim 23, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered orally.

35. The method of claim 34, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are orally administered in the form of a solid dose.

36. The method of claim 35, wherein the solid dose is in the form of a tablet or a capsule.

37. The method of claim 36, wherein the capsule is in the form of a sustained release capsule.

38. The method of claim 36, wherein the tablet is in the form of a sublingual tablet, a sustained-release tablet or a chewable tablet.

39. The method of claim 23, wherein the at least one hydralazine compound or a pharmaceutically acceptable sail thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide dinitrate is
administered in an amount of about 20 milligrams per day to about 200 milligrams per day.

40. The method of claim 23, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide mononitrate is
administered in an amount of about 10 milligrams per day to about 120 milligrams per day.

41. A method for treating hypertension in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about 30 milligrams per day to about 300 milligrams
per day and isosorbide dinitrate in an amount of about 20 milligrams per day to about 200 milligrams per day.

42. A method for treating hypertension in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about 30 milligrams per day to about 300 milligrams
per day and isosorbide mononitrate in an amount of about 10 milligrams per day to about 120 milligrams per day.

43. A method for improving exercise tolerance or for improving the quality of life in a black patient in need thereof comprising administering to the black patient a therapeutically effective amount of: (i) at least one hydralazine compound or a
pharmaceutically acceptable salt thereof; (ii) at least one of isosorbide dinitrate and isosorbide mononitrate; and (iii) optionally, one or more compounds selected from the group consisting of a digitalis compound, a diuretic compound, potassium, an
angiotensin-converting enzyme inhibitor, a beta-adrenergic blocker, a cholesterol reducer, a calcium channel blocker, an angiotensin II receptor antagonist, and an endothelin antagonist.

44. The method of claim 43, further comprising administering a pharmaceutically acceptable carrier.

46. The method of claim 43, wherein the hydralazine compound is hydralazine hydrochloride.

47. The method of claim 46, wherein the hydralazine hydrochloride is administered in an amount of about 30 milligrams per day to about 300 milligrams per day.

48. The method of claim 43, wherein the isosorbide dinitrate is administered in an amount of about 20 milligrams per day to about 200 milligrams per day.

49. The method of claim 43, wherein the isosorbide mononitrate is administered in an amount of about 10 milligrams per day to about 120 milligrams per day.

50. The method of claim 43, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered to the black patient as components of the same composition.

51. The method of claim 43, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered to the black patient as separate components.

52. The method of claim 43, wherein the black patient is male.

53. The method of claim 43, wherein the black patient is female.

54. The method of claim 43, wherein the black patient has hypertension.

55. The method of claim 43, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered orally.

56. The method of claim 55, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are orally administered in the form of a solid dose.

57. The method of claim 56, wherein the solid dose is in the form of a tablet or a capsule.

58. The method of claim 57, wherein the capsule is in the form of a sustained release capsule.

59. The method of claim 57, wherein the tablet is in the form of a sublingual tablet, a sustained-release tablet or a chewable tablet.

60. The method of claim 43, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide dinitrate is
administered in an amount of about 20 milligrams per day to about 200 milligrams per day.

61. The method of claim 43, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide mononitrate is
administered in an amount of about 10 milligrams per day to about 120 milligrams per day.

62. A method for improving exercise tolerance or for improving the quality of life in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about
30 milligrams per day to about 300 milligrams per day and isosorbide dinitrate in an amount of about 20 milligrams per day to about 200 milligrams per day.

63. A method for improving exercise tolerance or for improving the quality of life in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about
30 milligrams per day to about 300 milligrams per day and isosorbide mononitrate in an amount of about 10 milligrams per day to about 120 milligrams per day.

64. A method for treating heart failure in a black patient in need thereof comprising administering to the black patient a therapeutically effective amount of: (i) at least one hydralazine compound or a pharmaceutically acceptable salt thereof;
(ii) at least one of isosorbide dinitrate and isosorbide mononitrate; and (iii) optionally, one or more compounds selected from the group consisting of a digitalis compound, a diuretic compound, potassium, an angiotensin-converting enzyme inhibitor, a
beta-adrenergic blocker, a cholesterol reducer, a calcium channel blocker, an angiotensin II receptor antagonist, and an endothelin antagonist.

65. The method of claim 64, further comprising administering a pharmaceutically acceptable carrier.

67. The method of claim 64, wherein the hydralazine compound is hydralazine hydrochloride.

68. The method of claim 5, wherein the hydralazine hydrochloride is administered in an amount of about 30 mill ms per day to about 300 milligrams per day.

69. The method of claim 64, wherein the isosorbide dinitrate is administered in an amount of about 20 milligrams per day to about 200 milligrams per day.

70. The method of claim 64, wherein the isosorbide mononitrate is administered in an amount of about 10 milligrams per day to about 120 milligrams per day.

71. The method of claim 64, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered to the black patient as components of the same composition.

72. The method of claim 64, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered to the black patient as separate components.

73. The method of claim 64, wherein the black patient is male.

74. The method of claim 64, wherein the black patient is female.

75. The method of claim 64, wherein the black patient has hypertension.

76. The method of claim 64, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are administered orally.

77. The method of claim 76, wherein the at least one hydralazine compound and the at least one of isosorbide dinitrate and isosorbide mononitrate are orally administered in the form of a solid dose.

78. The method of claim 77, wherein the solid dose is in the form of a tablet or a capsule.

79. The method of claim 78, wherein the capsule is in the form of a sustained release capsule.

80. The method of claim 78, wherein the tablet is in the form of a sublingual tablet, a sustained-release tablet or a chewable tablet.

81. The method of claim 64, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide dinitrate is
administered in an amount of about 20 milligrams per day to about 200 milligrams per day.

82. The method of claim 64, wherein the at least one hydralazine compound or a pharmaceutically acceptable salt thereof is administered in an amount of about 30 milligrams per day to about 300 milligrams per day and isosorbide mononitrate is
administered in an amount of about 10 milligrams per day to about 120 milligrams per day.

83. A method for treating heart failure in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about 30 milligrams per day to about 300
milligrams per day and isosorbide dinitrate in an amount of about 20 milligrams per day to about 200 milligrams per day.

84. A method for treating heart failure in a black patient in need thereof comprising administering to the black patient hydralazine or a pharmaceutically acceptable salt thereof in an amount of about 30 milligrams per day to about 300
milligrams per day and isosorbide mononitrate in an amount of about 10 milligrams per day to about 120 milligrams per day.

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